FDA Releases 2 User Fee Implementation Plans

FDA has released two user fee-related implementation plans as part of the recent user fee reauthorization. The first is the “Resource Capacity Planning & Modernized Time Reporting Implementation Plan,” which outlines an approach to “develop capabilities that will help ensure that the FDA is making optimal use of its user fee financial resources to maximize its ability to efficiently and effectively deliver on its commitments to the public,” the agency says.

The second is the “Benefit-Risk Assessment in Drug Regulatory Decision-Making Implementation Plan,” which is an update to a 2013 implementation plan titled “Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making.” The new plan offers an update on CDER’s and CBER’s actions in implementing FDA’s Benefit-Risk Framework into regulatory review processes. It also outlines agency commitments under the reauthorized user fee program, including publication of a draft guidance on product benefit-risk assessments and how relevant patient experience data and other related information may be used to support the assessments.